PREMOM-II: Pregnancy Remote Monitoring of Women with Gestational Hypertensive Disorders

NACompletedINTERVENTIONAL
Enrollment

1,095

Participants

Timeline

Start Date

June 18, 2019

Primary Completion Date

February 1, 2024

Study Completion Date

February 1, 2024

Conditions
Gestational Hypertension
Interventions
DEVICE

Telemonitoring

Women who are allocated to the PSM groep, will receive a connected blood pressure monitor. They have to measure their blood pressure twice a day and fill in their weight once a week in the App. These data are automatically transmitted via Bluetooth and Wi-Fi to the hospital, but the caregiver will not see those data, and can not react to it.

OTHER

Longitudinal CV profiling during pregnancy and before and after the start/switch of antihypertensive medication

Longitudinal CV profiling during pregnancy and before and after the start/switch of antihypertensive medication Registration of medication usage in the Medisafe app Assessment of their beliefs about medicine in general and during pregnancy and their perceptions regarding medication adherence by means of the 'Beliefs about Medicine Questionnaire' and the 'Probabilistic Medication Adherence Scale' at baseline and postpartum.

OTHER

CV profiling before and after the start/switch of antihypertensive medication

CV profiling before and after the start/switch of antihypertensive medication Registration of medication usage in the Medisafe app Assessment of their beliefs about medicine in general and during pregnancy and their perceptions regarding medication adherence by means of the 'Beliefs about Medicine Questionnaire' and the 'Probabilistic Medication Adherence Scale' at baseline and postpartum.

Trial Locations (5)

2000

University hospital Antwerp, Antwerp

3000

Universitaire Ziekenhuizen Leuven, Leuven

3600

Ziekenhuis Oost-Limburg, Genk

8000

AZ Sint-Lucas Brugge - Oostende, Bruges

9000

AZ Sint Jan Brugge - Oostende, Bruges

All Listed Sponsors
collaborator

Ziekenhuis Oost-Limburg

OTHER

collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

collaborator

AZ Sint-Jan AV

OTHER

collaborator

AZ Sint-Lucas Brugge

OTHER

collaborator

University Hospital, Antwerp

OTHER

lead

Hasselt University

OTHER

NCT04031430 - PREMOM-II: Pregnancy Remote Monitoring of Women with Gestational Hypertensive Disorders | Biotech Hunter | Biotech Hunter